Prednisone is first-line treatment for pulmonary sarcoidosis and leads to improvement of pulmonary function and symptoms on short-term. However, prednisone can also lead to side-effects, which may negatively affect quality of life. Hence, patients and doctors report an urgent need for better evidence based first line treatment options. Methotrexate is considered as second-line treatment and seems to have fewer side-effects as reported in a patient survey. In the PREDMETH study we investigate the effectiveness of methotrexate compared with prednisone as first line treatment for pulmonary sarcoidosis. Furthermore, we examine blood biomarkers to assess whether response to therapy can be predicted in individual patients.

Methods
The PREDMETH study is initiated by the Erasmus Medical Center and St. Antonius Hospital Nieuwegein and developed in collaboration with the sarcoidosis patient association. This non-inferiority study takes place in 18 hospitals across the Netherlands. Patients will be randomized to treatment with prednisone or methotrexate in a predefined schedule for 24 weeks. Data will be collected at baseline, 4 weeks, 16 weeks, 24 weeks, 1 year and 2 years. Additionally, patients perform weekly home spirometry with a handheld spirometer and report symptoms and side-effects through an online home monitoring program (developed in collaboration with patients with sarcoidosis) during the first six months of the study. The primary endpoint is change in forced vital capacity at six months. Secondary endpoints are adverse events, quality of life and blood biomarkers. The study is currently recruiting patients. 

Discussion
This unique national study is developed by doctors, researchers and patients to provide better evidence based treatment for pulmonary sarcoidosis. If our hypothesis is confirmed and methotrexate is as effective as prednisone with less side-effect this will initiate a change in practice. Furthermore, the translational research will provide more insight to tailored treatment and the pathophysiological mechanisms of sarcoidosis.

Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis: the PREDMETH study

Sarcoidosis is a systemic granulomatous disease, mostly affecting lungs and lymph nodes. While in some patients disease activity resolves spontaneously, others have a more progressive disease course and require immunosuppressive therapy. Unfortunately, efficacy of therapy varies greatly between patients due to partial understanding of pathobiology and lack of specific biomarkers. Various markers like ACE, sIL-2R, T-cell subsets and monocytes have been evaluated in sarcoidosis over the past decades. However, a prospective study addressing the predictive value with regard to treatment response is lacking.
The PREDMETH study offers a unique opportunity to study existing and new biological markers, gain insights in disease pathogenesis and provide translational results for tailored treatment in sarcoidosis. 

The PREDMETH study is a national study, initiated by the Erasmus MC and St. Antonius Hospital and designed in collaboration with the sarcoidosis patient association. In this study efficacy and side-effects of methotrexate as first-line treatment option is compared with prednisone. Data and blood samples are collected at baseline, 4, 16, 24 weeks, and 1 and 2 years. 
To discover and validate markers that predict response to therapy absolute values at baseline of markers ACE and sIL-2R, monocyte and T-cell subsets and protein content of extracellular vesicles will be compared between responders and non-responders. To improve understanding of pathogenesis of sarcoidosis and response to therapy, changes in markers before and on treatment will be studied over time. Finally, all data will be combined to build a model for tailored treatment advice and pathophysiological response in sarcoidosis. 

This unique study combines clinical and fundamental research. We expect to provide new fundamental insights in markers for therapeutic response and cellular processes in the pathogenesis of sarcoidosis. Most importantly, this study holds promise to produce validated biomarkers that predict response to treatment and pave the way to tailored treatment in sarcoidosis.




Study design of the PREDMETH study: evaluation of immunological biomarkers that predict treatment response in pulmonary sarcoidosis

poster

[![](https://assets.underline.io/uploads/markdown_image/1/image/261902fdf187a88bfa74da226ff77186.png)](https://drive.google.com/file/d/1gUViQJJHCSgM38OhwpDoTdN89evCsZ-7/view?usp=sharing)
[![](https://assets.underline.io/uploads/markdown_image/1/image/1605292c232e6f185c7f87ee38e8502a.png)](https://drive.google.com/file/d/1kPkznVX_6cx-n846z_pUtyVDZql9KImc/view?usp=sharing)


### **Welcome Message**

Welcome to the inaugural **Dutch Lung Congress.**  We have all missed our opportunities to network and interact with our colleagues in the last twelve months or more.  While our desire was to meet face to face once again, when it became evident that this would not be possible until much later in 2021 (or even into 2022) the hard working committee organizing the Dutch Lung Congress found, what we hope will be, an excellent alternative to facilitate our annual meeting.

The Dutch Lung Congress aims to bring together everyone interested in research related to pulmonary diseases in the Netherlands.  We hope this event will provide opportunities for multidisciplinary interactions to enhance our approaches for addressing these challenging diseases.  Each session will include input from patients, clinical and basic and/or translational scientists discussing the latest information around the central themes chosen by the organizing committee.  One advantage of holding our congress as a virtual event this year is that we will have the opportunity to hear from world leading experts from all over the globe.  We hope you enjoy the programme the organizing committee have put together and will engage in dynamic discussions with all the speakers.

One highlight of our congress will be the Young Investigator Session.  Remember to join us for this exciting session when we will hear from the presenters who submitted the top scoring abstracts.  This promises to be a session full of exciting science that will display the strengths that constitute the future talent in our field.

When we are not listening to these great presentations we can all meet in Gathertown.  Within this interactive platform you will be able to meet colleagues and friends for networking. Enjoy a private chat over a virtual coffee, visit the booths of our sponsors and other parties, chat with the Young Investigator Board members or take some timeout in the relaxation spaces.  While in Gathertown take the opportunity to visit all the diverse posters on display. Chat live with the presenters or leave them a question on the discussion board for them to engage with you.  Make sure you check for any messages each time you enter Gathertown to make the most of your networking opportunities.

We look forward to seeing you during the DLC and the great scientific (and other) discussions we are anticipating during our 2021 meeting.

On behalf of the DLC organizing Committee
<br>**Janette Burgess
<br>Chair, DLC Organizing Committee**
![](https://assets.underline.io/uploads/markdown_image/1/image/f461fb275d9667fb2a76a30813388e90.png)



### Special Session: Publieksmiddag
![](https://assets.underline.io/uploads/markdown_image/1/image/77e768dd500e6205175e5cafba59abdc.png)






![](https://assets.underline.io/uploads/markdown_image/1/image/f461fb275d9667fb2a76a30813388e90.png)
**More about the committee team:**:
[Barbro N. Melgert, PhD] (https://drive.google.com/file/d/1q_IIH3JvTivumCUzzsZGX7BgD41HxQmk/view?usp=sharing)
// [Bas Holverda, PhD] (https://drive.google.com/file/d/1QKXHmTTQjgs4OZVuM8doXU055S-fu_uU/view?usp=sharing)
// [Frits Franssen, PhD] (https://drive.google.com/file/d/1d7HRUJaqGuRFzkPN3SVgkbBfqFkDkWq2/view?usp=sharing)
// [Janette Burgess, PhD] (https://drive.google.com/file/d/1VHFlrEN6uCQGeeW3Lj4I8aTw7HsB0GFr/view?usp=sharing)
// [Michel van den Heuvel, PhD] (https://drive.google.com/file/d/1JeOEP8MHxiK_4lONr8UM2HaxdxpkAmA2/view?usp=sharing)
// [Patrick Bhairosing] (https://drive.google.com/file/d/1xI8ORq-g1bbVcrlRDviZ9NhAwanc4dFl/view?usp=sharing)
// [Gimano Amatngalim, PhD] (https://drive.google.com/file/d/1fyVDDKARLNjRk_JZk8_GyhGMjmp6DWHp/view?usp=sharing)
// [Peter Kunst, PhD] (https://drive.google.com/file/d/1QhtB4nQezpAjbfUAcBnINc-Bm3Shy2Lf/view?usp=sharing)
// [Dr. Michel van den Heuvel, Prof., MD, PhD] (https://drive.google.com/file/d/1JBdNEBXZCEikEZhJ6MoD5DhQfXMz3bP6/view?usp=sharing)
![](https://assets.underline.io/uploads/markdown_image/1/image/f461fb275d9667fb2a76a30813388e90.png)

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Montse Janssen Bonás

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Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis: the PREDMETH study

Study design of the PREDMETH study: evaluation of immunological biomarkers that predict treatment response in pulmonary sarcoidosis

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